News about GMP/cGMP


ICH-Meeting in Charlotte, USA

The International Council for Harmonisation (ICH) met in Charlotte, USA, from 10 to 15 November 2018. The steadily increasing number of members (16) and observers (28) is an indication of the continuous development of the ICH into a global initiative. During the General Assembly, the Iranian authority NRA was welcomed as a new regulatory member.


For GMP, the following planning objectives were set by the relevant working groups:

  • Q2(R2)/Q14: Analytical Procedure Development and Revision of Q2(R1) Validation of Analytical Procedures
    Steps 1 and 2a/b are expected by June 2020.
  • Q13 EWG: Continuous Manufacturing
    Steps 1 and 2a/b are expected by June 2020.
  • Q3C(R8): Maintenance of the Guideline for Residual Solvents
    The Q3C(R8) Maintenance EWG continues its work on the development of PDE levels for the solvents 2- methyltetrahydrofuran, cyclopentylmethylether and tert-butanol.
    Steps 1 and 2a/b of ICH Q3C(R8) are expected by March 2019.
  • Q3D(R1)/(R2): Maintenance of the Guideline for Elemental Impurities
    Steps 3 and 4 of the Q3D(R1) revision to the Cadmium inhalation PDE are expected by early 2019.
  • Q11: Q&As on Selection and Justification of Starting Materials for the Manufacture of Drug Substances
    The finalisation of Training Material in form of a video with the narrated slide deck is expected by end of 2018.
  • Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
    Steps 3 and 4 are expected by November 2019.

The next general meeting is scheduled for 19-20 November 2019 in Singapore.


ICH: Press release

ICH: Meeting minutes